FDA Issues Warning for Users of Seizure Drug About Risk of Brain Inflammation Meningitis

By August 20, 2010July 18th, 2019Dangerous Drugs

The Food and Drug Administration has issued a worrisome new warning about Lamictal, a drug used to treat seizures in children and bipolar disorder in adults. According to the FDA, Lamictal (lamotrigine) can cause aseptic meningitis, an inflammation of the brain and spinal cord that is not caused by bacterial infection, like other types of meningitis. GlaxoSmithKline, Lamictal’s maker, says the risk of contracting aseptic meningitis from taking the drug is very rare, but the company agreed to change the drug’s label to include a warning about it. Russell Katz, MD, director of the Division of Neurology Productsof the FDA’s Center for Drug Evaluation and Research, said, “Aseptic meningitis is a rare but serious side effect of Lamictal use.” As a defective medication lawyer, I think it’s very important that doctors and patients be made fully aware of the risks associated with this drug so that they can make an informed decision about using it.
Patients taking Lamictal should be alert for signs of aseptic meningitis, which include headache, fever, stiff neck, nausea, vomiting, rash, and photophobia, or sensitivity to light. If they experience any of these symptoms, they should contact their health care professional right away. To diagnose the condition, doctors have to perform a spinal tap on the patient and examine a sample of spinal fluid.
Between Lamictal’s FDA approval in December 1994 and the FDA’s review of adverse event reports undertaken after November 2009, the FDA had received 40 reports of aseptic meningitis in both adult and pediatric patients taking Lamictal. The symptoms started within 1 to 42 days of starting the drug. Thirty-five patients had to be hospitalized, and one died, though the death was not thought to have been caused by meningitis. The 35 patients who were hospitalized recovered when they stopped taking Lamictal. Fifteen of them saw even worse symptoms return within just a few hours when they started taking the drug again. Forty-six million prescriptions for Lamictal had been dispensed during this period.
Aseptic meningitis is not the only significant but rare risk associated with this drug. A few months ago, I wrote about Lamictal users’ increased risks of suicidal thoughts and suicide attempts. The drug also carries a black box warning about the drug’s association with Stevens-Johnson syndrome, an often-fatal kind of rash. As GlaxoSmithKline works to increase its sales despite Lamictal going generic in 2009, pharmaceutical liability attorneys like me worry that the company and others like it will stop paying as much attention as they should to patients’ safety. Drug companies are well aware that they have a responsibility to warn patients, doctors, and the FDA about risks associated with their products. But unfortunately, we regularly see drug companies fail to do so when they are more focused on money than medicine. Because the law requires them to warn the public, if they fail to do so and an unsuspecting patient is harmed by a defective drug, the drug maker can be held legally and financially accountable.

Consumers who have been hurt by dangerous or contaminated drugs can sue drug companies that failed to warn them about the dangers of their products. Resolving medical issues caused by dangerous drugs is frequently very expensive, even with health insurance, when it involves hospitalization and the expertise of health care professionals, who don’t work for free. Patients often lose money because they miss work due to illness and medical appointments, and permanent injuries guarantee at least some reduction in their quality of life. People who have been hurt in these ways can sue the drug companies that caused the harm, to recover all these costs as well as compensation for pain and suffering and other personal losses. If you have been harmed by a contaminated or defective medication, please call the defective drug liability lawyers at Carey, Danis & Lowe for a free consultation. We will help you understand your rights and your options, and we’ll fight hard to get you the compensation that’s rightfully yours. You can reach us toll-free at 1-877-678-3400 or through our website.